đź“‹ FDA Reference
Titan Micro Catheter Model 105-5074-153 HD Injector Model 103-0305
Summary: The Titan Micro Catheter is a medical device used for delivering embolization coils in vascular procedures. It is primarily used by interventional radiologists and neurosurgeons for treating aneurysms and other vascular abnormalities.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K022003 ↗
Decision Date ?
September 13, 2002
Product Code ?
DYB
Device Class ?
Class 2
Evidence ?
0 studies
The Titan Micro Catheter, manufactured by Micro Therapeutics, was cleared through the FDA 510(k) pathway on September 13, 2002. It is classified as a Class 2 device under product code DYB.
What It Is
The Titan Micro Catheter is a specialized catheter designed for precise delivery of embolization coils into blood vessels. It features a flexible, small-diameter design that allows navigation through complex vascular structures. This device is crucial in minimally invasive procedures where access to small or tortuous vessels is required.
FDA-Cleared Indications
- Delivery of embolization coils through the vascular system during endovascular procedures.
- Use in treating vascular abnormalities for which coil embolization is indicated, such as aneurysms.
Clinical Applications
- Endovascular delivery of embolization coils to a target blood vessel.
- Coil embolization of selected cerebral aneurysms.
- Coil embolization of selected peripheral or visceral vascular abnormalities when the anatomy and coil system are appropriate.
Reported off-label uses
- Delivery of other embolic materials or adjunctive devices may be reported in clinical practice, but this is not necessarily within the device's FDA-cleared labeling.
- Use in selected arteriovenous malformation embolization procedures may occur in practice; the specific indication depends on the catheter labeling, embolic agent, and treatment plan.
Off-label use: these uses are reported in practice or the literature but are not part of the FDA-cleared indications. Physicians may use a cleared device off-label based on their medical judgment; the manufacturer may not promote off-label uses.
Practical Considerations
- The catheter is available in configurations intended for navigation through small or tortuous vessels; the exact usable size and compatibility must be confirmed in the current manufacturer instructions for use.
- It should be used with compatible embolization coils and standard fluoroscopic or angiographic imaging equipment.
- Navigation and coil deployment require training in endovascular catheter techniques because vessel injury, dissection, perforation, thrombosis, or unintended embolization can occur.
- MRI safety is not established by the information provided in this FDA record. Check the current labeling for the specific catheter and injector before MRI.
- Contraindications and warnings should be taken from the current manufacturer labeling and the planned embolization procedure; they may include unsuitable vascular anatomy, inability to access the target vessel, active infection, or contraindication to angiography or embolization.
Procedures that use this device
Frequently Asked Questions
What is the Titan Micro Catheter used for?
It is used for delivering embolization coils to treat vascular abnormalities such as aneurysms.
What specialties typically use this device?
Interventional radiologists and neurosurgeons typically use this device.
What are the FDA-cleared indications?
The device is indicated for the delivery of embolization coils in treating vascular abnormalities like aneurysms.
Disclaimer: This page compiles publicly available regulatory and published clinical evidence for educational reference.
It does not constitute medical advice, product endorsement, or a recommendation for clinical use.
Always consult manufacturer documentation and clinical judgment for patient care decisions.